FDA 510(k) Application Details - K250136

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K250136
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Globalcare Medical Technology Co., Ltd No.7 Factory, European Industrial Park, No. 39 Mid Industrial Main Road Xiaolan Town, Zhongshan City Guangdong 528415 CN Other 510(k) Applications for this Company
Contact	Valentina Sassi Other 510(k) Applications for this Contact
Regulation Number	870.1130   More FDA Info for this Regulation Number
Classification Product Code	DXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/17/2025
Decision Date	04/08/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review